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LTP001 for Pulmonary Arterial Hypertension

Phase 1 & 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy males and non-child-bearing potential females
Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care PAH therapies, 6-minute walk distance ≥ 150 m and ≤450 m.
Must not have
Women of child-bearing potential unless they are using highly effective methods of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 18

Summary

This trial aims to investigate the effects of a treatment called LTP001 in both healthy individuals (Part A) and individuals with Pulmonary Arterial Hypertension (PAH) (Part B

Who is the study for?
This trial is for healthy males and females who can't bear children (Part A), and individuals with Pulmonary Arterial Hypertension (PAH) (Part B). Specific details on who can't participate are not provided, but typically those with other serious health issues or conflicting medications would be excluded.
What is being tested?
The study is testing a new treatment called LTP001. In Part A, it's given to healthy participants to assess safety and tolerability. In Part B, the effects of LTP001 on people with PAH are studied. Some will receive a placebo instead of the actual drug to compare outcomes.
What are the potential side effects?
Since specific side effects aren't listed for LTP001, common ones may include headache, nausea, dizziness or reactions at the injection site if applicable. Placebo generally has no active ingredients but some report mild symptoms due to their expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy male or a female not able to bear children.
Select...
I have PAH, am on stable PAH medication, and can walk between 150m and 450m in 6 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am using reliable birth control methods if I can become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR)
Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Secondary study objectives
Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
Part A- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
Part A- Maximum observed plasma concentrations (Cmax)
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LTP001 Dose 3Experimental Treatment1 Intervention
Group II: LTP001 Dose 2Experimental Treatment1 Intervention
Group III: LTP001 Dose 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
matching placebo

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,471 Total Patients Enrolled
11 Trials studying Pulmonary Arterial Hypertension
565 Patients Enrolled for Pulmonary Arterial Hypertension
~155 spots leftby Aug 2026
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